Registration Dossier
Registration Dossier
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EC number: 286-081-5 | CAS number: 85186-95-4
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No effects up to the limit of water solubility for Daphnia magna (OECD 202); read-across
Key value for chemical safety assessment
Additional information
Since no studies investigating the short-term toxicity to aquatic invertebrates of Fatty acids, C12-16, esters with neopentyl glycol (CAS No. 85186-95-4) are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5, a read across to the structurally most similar category members 2,2-dimethyl-1,3-propanediyl dioleate (CAS No. 42222-50-4) and Fatty acids, C8-18 and C18-unsatd., esters with neopentyl glycol (CAS No. 85186-86-3) was conducted. Further justification is given within the endpoint summary 6.1 and within the category justification in IUCLID section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment. Nevertheless, as it can be seen in the data matrix of the category justification in section 13 and the overall summary, all reliable data in the category support the hazard assessment by showing a consistent pattern of results.
The key study conducted with 2,2-dimethyl-1,3-propanediyl dioleate (CAS No. 42222-50-4) was performed as a limit test according to OECD Guideline 202 (Häner, 2006). The test organism Daphnia magna was exposed to the test substance in a static system for 48 hours, at the nominal test concentration of 100 mg/L. No significant immobilisation was observed, and the EC50 (48 h) was reported to be > 100 mg/L.
The key study conducted with Fatty acids, C8-18 and C18-unsatd., esters with neopentyl glycol (CAS No. 85186-86-3) was performed as a limit test according to OECD Guideline 202 and GLP, in a static system (Häner, 2007). The test organism Daphnia magna was exposed to the test substance at the nominal test concentration of 100 mg/L for 48 hours. The test solutions were prepared as water accommodated fractions (WAF). No immobilisation was observed during the study, and the EL50 (48 h) was reported to be > 100 mg/L.
Thus, based on the above mentioned results, and due to the structural and profile similarities of the substances, as are explained in the overall endpoint summary 6.1 it can be concluded that no toxicological effects on aquatic invertebrates are expected up to the limit of water solubility for Fatty acids, C12-16, esters with neopentyl glycol. As it can be seen in the data matrix of the category justification in section 13 and the overall summary, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results within the polyol esters category.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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